BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION(TM) MP FEM

    MDR report key: 5242598 · Received November 23, 2015

    Report

    Report Number
    3010536692-2015-01940
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    February 27, 2013
    Report Date
    November 11, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2015-01941, -01942, & -01943.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT REVISED DUE TO SUBSTANTIAL PAIN AND SUFFERING; LIMITED MOVEMENT OF THE KNEE AND NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773594 EVOLUTION(TM) MP FEM KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. 079894056

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention